Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Safety and efficacy of renal denervation
研究概览
简要总结
The study is aiming to document the long-term safety and effectiveness of renal denervation in patients with hypertension and other diseases characterized by elevated sympathetic drive. Catheter-based renal denervation will be performed using CE marked, percutaneous, systems.
详细描述
Inclusion Criteria
- Individual is 18 years of age.
- Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
- Patient scheduled for renal sympathetic denervation using market-released device.
Exclusion Criteria
- In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.
- Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual is 18 years of age.
- •Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
- •Patient scheduled for renal sympathetic denervation using market-released device.
排除标准
- •In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.
- •Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).
结局指标
主要结局
Safety and efficacy of renal denervation
时间窗: Baseline to 6 months
Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure). Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
次要结局
- Effect of renal denervation on different organ systems.(Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months)
- Safety and efficacy of renal denervation(Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months)
